Director, Quality Operations and Quality Control

Veranova • Devens, MA

4d • Onsite

About The Position

The Director, Quality Operations and Quality Control leads the Quality Operations function and Quality Control test labs for the Veranova sites located in Devens, MA and North Andover, MA. In collaboration with site Leadership, it is the responsibility of this role to ensure the day to day Quality Assurance aspects of manufacturing, testing, reporting, issue resolution and batch disposition of active pharmaceutical ingredients, intermediates meet the compliance requirements applicable to drug substance manufacturing of pharmaceutical products. This position is fully onsite first shift at our Devens, MA facility.

Requirements

• BS or equivalent in Chemistry or related Science
• 15+ years experience within GMP Quality Assurance and Quality Control in an FDA/EMA regulated industry;
• 10+ years directly managing performance and development of staff members
• 7+ years experience with batch production, control and disposition processes and QC Laboratory testing
• Expert knowledge in Root Cause Analysis, Investigations, CAPA and CAPA Effectiveness;
• Familiarity with Veeva, Master Control, LIMS and ERP systems;
• Experience within Drug substance manufacturing;
• Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
• Expert knowledge in process validation, production equipment qualification, environmental controls, and change management;
• Experience with customer complaint investigations
• Knowledge of basic microbiology and contamination control as they apply to drug substance manufacturing, specifically bioconjugation operations
• Ability to Plan, Organize, Prioritize and Monitor workload across multiple sites and customer projects;
• Familiarity with risk management principles and capable of decision making based on risk management;
• Ability to independently interact with customers, vendors, and regulatory inspectorates
• Familiarity with project management and ability to lead improvement projects across multiple sites
• Strong experience with Microsoft Office applications, including Word, Excel and PowerPoint

Responsibilities

• Aids in the creation of the Quality Operations (QO) and Quality Control (QC) strategy and implementation of the strategy at the site; Creates QC/QA workload planning, contributes to site budgeting, headcount and resource loading based on required skill sets and available assets
• Assures the standards and QO oversight of batch production monitoring, quality control and release requirements are executed to ensure batch compliance with GMPs and regulatory filings. Including stopping manufacture or distribution of a product if necessary.
• Leads or advises on root cause analysis performed to investigate manufacturing deviations, critical events, customer complaints, audit findings related to production or trends in quality metrics; Ensures compliance with QMS during production and testing including investigations, CAPA and Change Management.
• Support implementation and execution of LIMS, TrackWise improvements and other E-systems projects.
• In collaboration with Regulatory Affiars and QC, manage stability programs to support commercial products as well as new submissions, according to the ICH guidelines and zone requirements;
• Develop, improve, and revise Standard Operating Procedures testing monographs;
• Monitors documentation practices to assess data integrity during the production, testing, review of products for clinical or commercial use;
• Actively engages or leads teams in product or process/product technology transfers and method transfers across sites.
• In collaboration with site VP/GM, presents Quality Performance metrics to Executive leadership during quarterly management review meetings; Engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement; Participate in Site leadership team to execute overall business priorities;
• Manages, coaches and develops site Quality team members for the purpose of both professional development and succession planning
• Engages with peer across regions to coordinate/harmonize product monitoring and disposition requirements as well as evaluate investigation trends and audit findings within and across sites to facilitates team discussion on proper global CAPA.
• Assures proper execution of process, product and method validation through review, guidance and approval of protocols and final reports verifying compliance with regulatory expectations;
• Oversees the QC laboratory and interacts with production floor operations which require safety training and proper use of PPE applicable to the facility and operation.
• Engages and leads discussions with customers as needed to resolve complaint issues, audit observations, or quality agreement terms;
• Leads the sites during Regulatory Agency Inspections and customer audits.
• Assists with DEA compliance requests as needed.
• Responsible for the Quality execution which requires intermittent travel within the region and periodically across sites for engagement with peers, site functional leaders, customers and strategy meetings.
• Carries out any other duties within the employee’s skills and abilities whenever reasonably

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• Competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director